D
Patient 1
THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF A SEIZURE IN A (B)(6) FEMALE PT WHO RECEIVED TRIPLE SALT DENTAL ADHESIVE CREAM (POLIGRIP EXTRA STRENGTH) FOR AN UNK INDICATION. CO-SUSPECT PRODUCTS INCLUDED DOUBLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP EXTRA CARE WITH POLISEAL (ZINC FREE FORMULA)) (BATCH NUMBER Z07082A, EXP DATE UNK) FOR AN UNK INDICATION. ON AN UNK DATE, THE PT STARTED POLIGRIP EXTRA STRENGTH AND SUPER POLIGRIP EXTRA CARE WITH POLISEAL (ZINC FREE FORMULA). ON AN UNK DATE, AND UNK TIME AFTER STARTING POLIGRIP EXTRA STRENGTH AND SUPER POLIGRIP EXTRA CARE WITH POLISEAL (ZINC FREE FORMULA), THE PT EXPERIENCED SEIZURE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), VASCULAR RUPTURE AND BRAIN OPERATION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). POLIGRIP EXTRA STRENGTH AND SUPER POLIGRIP EXTRA CARE WITH POLISEAL (ZINC FREE FORMULA) WERE DISCONTINUED (DECHALLENGE WAS POSITIVE). ON AN UNK DATE, THE OUTCOME OF THE SEIZURE, VASCULAR RUPTURE, AND BRAIN OPERATION WERE RECOVERED/RESOLVED. THE REPORTER CONSIDERED THE SEIZURE AND VASCULAR RUPTURE TO BE POSSIBLY RELATED TO POLIGRIP EXTRA STRENGTH. IT IS UNK IF THE REPORTER CONSIDERED THE BRAIN OPERATION TO BE RELATED TO POLIGRIP EXTRA STRENGTH AND SUPER POLIGRIP EXTRA CARE WITH POLISEAL (ZINC FREE FORMULA). IT WAS UNK IF THE REPORTER CONSIDERED THE SEIZURE AND VASCULAR RUPTURE TO BE RELATED TO SUPER POLIGRIP EXTRA CARE WITH POLISEAL (ZINC FREE FORMULA). THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY AND ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ON (B)(6) 2015, THE CONSUMER CALLED TO INQUIRE ABOUT THE USE OF SUPER POLIGRIP EXTRA CARE PRE AND POST ZINC. SHE WANTED TO KNOW IF WE HAD ANY REPORTS OF BLOOD VESSEL BLEEDS CAUSING SEIZURES IN REGARD TO THE PRODUCT. SHE REPORTED USING THE PRODUCT FOR 12 YEARS, SOME OF WHICH WERE WHEN THE PRODUCT STILL CONTAINED ZINC. THREE YEARS AGO SHE QUIT USING THE PRODUCT SUBSEQUENT TO BRAIN SURGERY AND NEVER HAD THE ISSUES AGAIN. HER NEUROLOGIST INFORMED HER THAT ZINC COULD POSSIBLY BE THE CAUSE OF HER SEIZURES AND BLOOD VESSEL BLEEDS.